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March 19, 2014
Articles

Attempts to Outsmart the FDA Could Lead to Mass Torts

By Deborah L. Shuff

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On January 30, 2014, the United States brought suit against Valor Medical, Inc., a medical-device manufacturer—as well as the company’s CEO, manager of clinical and regulatory affairs, president, and chief chemist—in the U.S. District Court for the Southern District of California, alleging violations of the Federal Food, Drug, and Cosmetic Act for failure to furnish preclinical data with its investigational device exemption (IDE) application to the Food and Drug Administration (FDA). United States v. Valor Medical, Inc., No. 14-cr-00196 (S.D. Cal. Jan. 30, 2014).

Valor is a biomedical-device manufacturer that created Neucrylate, a liquid product that was designed to treat aneurysms in the brain and near the heart. “Valor Medical Reports Early Clinical Results of New Technology to Treat Cerebral Aneurysms,” PR Newswire. Neucrylate is a 1-hexyl n-cyanoacrylate compound that, by way of catheter, is injected into an aneurysm and becomes sponge-like upon contact with the aneurysm. Early studies reportedly yielded positive results.